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Human Factors Considerations | FDA

    https://www.fda.gov/medical-devices/human-factors-and-medical-devices/human-factors-considerations
    A device user interface includes all points of interaction between the user and the device, including all elements of the device with which the user interacts. A device user interface might be used while user setups the device (e.g., unpacking, set up, calibration), uses the device, or performs maintenance on the device (e.… See more

Software User Interface Requirements for Medical Devices

    https://www.mddionline.com/news/software-user-interface-requirements-medical-devices
    HFE in medical devices is somewhat different from that in other industries in one important way: The optimum and preferred designs for a device are not necessarily …

Association for the Advancement of Medical …

    https://www.aami.org/docs/default-source/uploadedfiles/publications/mdii-compendium.pdf
    Association for the Advancement of Medical Instrumentation

Making Medical Device Interfaces More User-Friendly

    https://www.mddionline.com/news/making-medical-device-interfaces-more-user-friendly
    User-interface designs such as those associated with patient monitors, ventilators, blood chemistry analyzers, infusion pumps, and kidney dialysis machines …

EU MDR language requirements — what manufacturers …

    https://decomplix.com/eu-mdr-language-requirements/
    In the following blog post, you will get practical answers on how the languages are regulated in the MDR. The introduction of the new Medical Device …

Mandatory Languages Requirements for Medical Devices

    https://www.team-nb.org/wp-content/uploads/2015/05/documents2012andolders/MDEG_-_2008-12_-_II-6.3._Mandatory_Languages_Requirements_for_Medical_Devices_update_Sept.08.pdf
    language, all other parts of the User Manuals can be in English (for the all MD). User Interface can be in English, provided that the information required for the safe use of the …

Medical Device Software - User Interface Language

    https://elsmar.com/elsmarqualityforum/threads/medical-device-software-user-interface-language-93-42-ce.35715/
    If a medical device manufacturer’s software is classified as a medical device under Directive 93/42/EEC, then the software should be in the country’s official …

Mandatory Language Requirements for Medical Devices

    https://www.johner-institut.de/blog/wp-content/uploads/2015/10/020205_Mandatory_Language.pdf
    Depending on the Medical Devices Directive (93/42/EEC)- MDD - the member states of the European Economic Area, EEA, can require their own language. All of them have written …

Worldwide Language Requirements for Medical Device …

    https://www.argosmultilingual.com/blog/worldwide-language-requirements-for-medical-device-translations
    Middle East/Africa English – Egypt, Ghana, Israel, Kenya, Namibia, Nigeria, Saudi Arabia, Sierra Leone, South Africa, Tanzania, Uganda,... Hebrew – Israel (labeling for home-use medical devices) …

TCP & HL7 Streaming Interface - MediCollector

    https://www.medicollector.com/uploads/3/1/0/6/31064385/medicollector_-_tcp___hl7_streaming_interface.pdf
    application or system. Using this interface, you can send live signals from one of our supported medical devices directly into your own application or system. Please note the …



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